Kornimate/medical-research-clean huggingface dataset:
dietary restriction as an adjunct to neoadjuvant chemotherapy for her2 negative breast cancer

Conditions: Fasting Mimicking Diet; Breast Cancer; Neoadjuvant Chemotherapy; Pathological Complete Response

Summary: preclinical studies provide strong support for the concept that fasting evokes resistance to multiple forms of stress. fasting reduces plasma levels of growth factors and modulates intracellular nutrient sensing systems, thereby diverting energy from growth to maintenance. accordingly, the currently available preclinical evidence suggests that short-term fasting protects normal cells against the perils of chemotherapy. in contrast, cancer cells are not protected, as a result of their self-sufficiency in growth signals. this phenomenon is termed differential stress resistance (dsr). dsr reduces the severity of toxic side-effects of chemotherapy and interestingly, it simultaneously renders cancer cells more vulnerable to chemotherapeutics. importantly, extensive preclinical evidence and preliminary clinical data indicate that a specifically designed very low calorie, low amino acid substitution diet ("fasting mimicking diet, fmd") has effects on cancer therapy that are very similar to those of fasting. this study aims to evaluate the impact of the fmd on tolerance to and efficacy of neoadjuvant chemotherapy in women with stage ii or iii breast cancer.


Eligibility criteria:
inclusion criteria: * female patients with stage ii or iii (ct1cn+ or ≥t2 any cn, cm0) breast cancer receiving neoadjuvant ac-t * measurable disease (breast and/or lymph nodes) * her2 negative core biopsy age ≥18 years * who performance status 0-2 * adequate bone marrow function : white blood cells (wbcs) ≥3.0 x 109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l * adequate liver function: bilirubin ≤1.5 x upper limit of normal (unl) range, alat and/or asat ≤2.5 x unl, alkaline phosphatase ≤5 x unl * adequate renal function: the calculated creatinine clearance should be ≥50 ml/min * patients must be accessible for treatment and follow-up * written informed consent according to the local ethics committee requirements * willing to fill in quality of life questionnaires * able to read and write in dutch exclusion criteria: * history of breast cancer (invasive or non-invasive) * previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix. * serious other diseases such as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias * diabetes mellitus * body mass index (bmi) \< 19 kg/m2 * pregnancy or lactating * significant food allergies which would make the subject unable to consume the food provided (ex: nuts or soy) * any metabolic disorders that may affect gluconeogenesis or adaptation to short fasting periods. * medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
lumbar paraspinal muscular properties after cesarean delivery

Conditions: Low Back Pain, Mechanical

Summary: the biomechanical characteristics of lumbar paraspinal muscles may give us insight into different lower back dysfunctions in postpartum mothers after cesarean section.

stiffness and elasticity are two mechanical characteristics of the muscles, whereas relaxation time and creeping are two viscoelastic characteristics. different studies investigated the mechanical properties of lumbar paraspinal muscles in numerous musculoskeletal conditions, however, no previous studies investigated these characteristics after cesarean section, which is associated with high prevalence of lower back pain when compared with normal delivery.

Eligibility criteria:
inclusion criteria: * women who experienced cesarean section at least for one time * women who are free of specific lower back disorders * women who are below 34 years old and above 20 years old exclusion criteria: * women who experienced normal vaginal birth * women who complain of a specific lower back disorder * women who are above 34 years old or below 20 years old * women who have a body mass index above 30 kg/m2
a study of open angle glaucoma or ocular hypertension in patients within the united kingdom

Conditions: Ocular Hypertension; Open Angle Glaucoma

Summary: study phxa41 for its non-inferiority compared with timolol in lowering intra-ocular pressure


Eligibility criteria:
inclusion criteria: * unilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension. * open angle glaucoma appearing more than 6 months after cataract surgery is recognized as primary open angle glaucoma. (individuals requiring treatment bilaterally must fulfill eligibility criteria for both eyes.) * iop of 22mmhg or higher obtained during the pre-study period. * patients currently not treated or on single-drug treatment for the elevated iop are eligible after a medication free period (wash-out) of: 1. 3 weeks for b-adrenergic antagonists 2. 2 weeks for adrenergic agonists 3. 5 days for cholinergics and oral carbonic anhydrase inhibitors. exclusion criteria: * history of acute angle closure. * severe trauma at any time. * intraocular surgery or argon laser trabeculoplasty within 6 months. * current use of contact lenses. * history of severe dry eye syndrome. * ocular inflammation/infection with three months of inclusion. * any condition preventing reliable applanation tonometry. * unacceptable finding at pre-study ocular examination as specified in the case report forms. * in investigator regards monotherapy insufficient with respect to optic nerve head and/or visual field status. * treatment of elevated iop with any topical b-adrenergic antagonist regularly for a period longer than 3 months and/or treatment at any time during 6 months prior to study start. * cardiac failure, sinus bradycardia, second and third degree of atrio-ventricular block. * bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease. * having participated in any other clinical study within the last month.

Keywords: open angle glaucoma ocular hypertension
stimulation test with intranasal glucagon for corticotroph, somatotroph and antidiuretic axes

Conditions: Hypopituitarism

Summary: the diagnosis of secondary hypoadrenalism and gh deficiency (ghd) often requires the performance of a dynamic test. the glucagon stimulation test (gst) is one of the options for evaluating hypothalamic-pituitary function, representing a stimulus for both the corticotropic and somatotropic axis, substantially safe and easily available. the standard procedure involves the intramuscular injection of 1-1.5 mg of glucagon based on the patient's weight. in addition to its antero-pituitary function, glucagon has also shown its ability to stimulate neurohypophyseal secretion. using the copeptin dosage, it has been shown that after the administration of glucagon in healthy subjects there is a significant release of adh. however, the available data are scarse and there is no standardized protocol for the use of the glucagon test in diabetes insipidus. at the moment, gst is not the most frequently chosen diagnostic option. in fact, despite having the advantage of being able to investigate different areas of anterohypophyseal and probably posterohypophyseal function at the same time, the test has some disadvantages: the prolonged duration makes the procedure challenging, the intramuscular injection can be unwelcome, and many variables can come into play in the definition of a normal response (age, bmi, glycemic status). the recent introduction of a single-dose nasal powder formulation (baqsimi®) could overcome some of the limitations of classic gst and make the procedure less demanding. to date, no assessments are yet available regarding a purely diagnostic role in the context of hypopituitarism of this new formulation. through the knowledge of the physiological response of the adrenocortical, somatotropic and adh axis to the administration of intranasal glucagon in healthy subjects, it will be possible to evaluate its possible application in the diagnosis of gh deficiency, central adrenal insufficiency and possibly diabetes insipidus.


Eligibility criteria:
inclusion criteria: - any adult healthy subject (age \>= 18 years old) and not meeting the exclusion criteria listed below exclusion criteria: * bmi \ 25 kg/m2 * any active pharmacological treatment * pregnancy or breastfeeding
an effectiveness and safety study of idea-033 in comparison to oral naproxen and placebo for the treatment of osteoarthritis of the knee

Conditions: Osteoarthritis, Knee

Summary: the purpose of this study is to identify the dose(s) of idea-033 that will provide a meaningful effect for treating osteoarthritis of the knee.

the objective of this double-blind, placebo-controlled, randomized study is to evaluate the safety of and to identify the dose(s) of idea-033 that will provide a minimum clinically meaningful effect for treating the signs and symptoms of osteoarthritis of the knee. this study will also compare the safety profile of the three doses of idea-033 in treating the signs and symptoms associated with osteoarthritis for 12 weeks. the primary hypothesis is that at least one of the three doses of idea-033 is superior to placebo with respect to three primary efficacy endpoints of womac pain, womac physical function, and subject global assessment of response to therapy. a second hypothesis is that there is an increase in efficacy with increasing doses of idea-033. patients will receive one of five treatments for 12 weeks:three doses of idea-033, or naproxen 1 g over-encapsulated tablet + placebo or placebo

Eligibility criteria:
inclusion criteria: * osteoarthritis of both knees for minimum of six months * moderate pain in the most involved knee when not taking nsaids * must have used an oral nsaid on at least three days per week for last three months or 25 of 30 days before screening * demonstrate x-ray evidence of osteoarthritis in the most involved knee during the last six months exclusion criteria: * grade 1 or grade 4 severity of the most involved knee based on x-ray criteria * intra-articular injections or arthroscopy of the most involved knee during three months before screening visit * inflammation of the most involved knee that could be related to gout or pseudogout-induced synovitis or infection * a large bulging effusion * history of gout or pseudo-gout induced synovitis or infection of the more severe knee * history of partial or total knee replacement in either knee

Keywords: osteoarthritis
clinical benefit and biomarker analysis of combination of pd-1/pd-l1 immune checkpoint inhibitors and radiotherapy

Conditions: HNSCC; NSCLC; Esophageal Cancer; Urothelial Carcinoma; Renal Cell Carcinoma; Squamous Cell Carcinoma of the Skin; Small Cell Bronchial Carcinomas

Summary: inhibitors of the programmed cell death protein 1 (pd-1)/pd-l1 immune checkpoint signaling pathway are already approved in the treatment of various tumor entities in relapsed or metastatic stages. different exploratory trials suggest that the combination of radiotherapy and pd-1/pd-l1 inhibitors is highly effective, especially in oligometastatic stages and if all lesions are treated with ablative radiotherapy. in addition, the role of predictive biomarkers is becoming increasingly important for future therapy algorithms. first data, also from our group, indicate clearly that dynamic changes of immune cells and their activation markers in the peripheral blood (immune matrix) can be used as predictive biomarkers. during the planned stici-02 trial predictive immune matrix derived from the stici01 trial (nct03453892) will be validated in the groups of patient suffering from hnscc (palliative), nsclc (separately palliative and adjuvant) and "other solid tumors" (including in particular esophageal carcinomas, urothelial and renal carcinomas, small cell bronchial carcinomas and squamous cell carcinomas of the skin \[depending on the current drug approval\]). within the framework of scientific accompanying projects, the predictive value of markers in tumor tissue and of pattern radiomics analyses will be analyzed accompanying the immunophenotyping in peripheral blood. the side effects


Eligibility criteria:
inclusion criteria: * patients treatable for hnscc (palliative), nsclc (separately palliative and adjuvant) or "other solid tumour" * indication for system therapy with a pd-1/pd-l1 inhibitor according to clinical standards * patients without or with radiation of one or more metastases * age at least 18 years exclusion criteria: * melanoma patients * fertile patients who refuse effective contraception during study treatment * persistent drug and/or alcohol abuse * patients not able or willing to behave according to study protocol * patients in care * patients that are not able to speak german * patients which are imprisoned according to legal or governmental order both gender are included into the study, a maximum age was not defined.

Keywords: immunotherapy radiotherapy
acupuncture for tonsillectomy pain

Conditions: Children; Postoperative Pain; Tonsillar Hypertrophy; Obstructive Sleep Apnea; Chronic Tonsillitis

Summary: pain after tonsillectomy can be severe and last ten days. various new surgical instruments have been developed over the years in an attempt to reduce postoperative pain with mixed results and increased costs; no single tonsillectomy technique is superior to the rest. patients are discharged to home usually on the day of surgery and often suffer significant pain and nausea. pain medication is often prescribed which can cause nausea, vomiting and constipation. children in pain are reluctant to take in fluids and may require intravenous hydration at an emergency department. "battlefield acupuncture " has been recently developed by the us air force and is now being used in iraq and afghanistan on wounded warriors suffering severe acute pain from trauma. this protocol consists of five acupuncture points on the outer ear. a recent study has demonstrated decreased pain and agitation in children undergoing ear tube insertion. ear tube patients have mild discomfort compared to tonsillectomy patients and are able to attend school the next day. the investigators have been encouraged by the benefits of acupuncture during surgery for ear tube patients and also wounded warriors recovering from their injuries. these findings motivated us to see if acupuncture during tonsillectomy surgery would result in less pain and nausea.


Eligibility criteria:
inclusion criteria: * children 2 to 17 years of age who need tonsillectomy with or without adenoidectomy with or without myringotomy tube(s) exclusion criteria: * developmental delay

Keywords: tonsillectomy adenotonsillectomy acupuncture children postoperative pain postoperative nausea
cardiac and vascular late sequelae in long-term survivors of childhood cancer (cvss)

Conditions: Childhood and Adolescence Cancer (Survivors and Deceased)

Summary: due to remarkable advances in childhood cancer therapy the 10-year survival rate increased to over 80% and late sequelae come to the fore. childhood cancer survivors (ccs) suffer from significant excess in mortality risk associated with treatment-related complications at least for 25 years after the initial cancer diagnosis. in particular, the prevalence of cardiovascular disease seems to be elevated compared to the general population. the cvss study is a multi-disciplinary cooperation project between the institute for medical biostatistics, epidemiology and informatics (imbei) and the german childhood cancer registry (gccr), the preventive cardiology and preventive medicine and the pediatric hematology and oncology all at the university medical center of the johannes gutenberg university mainz. the central element is a thorough clinical cardiovascular examination of all patients, which permits detecting subclinical disease. therapy data will be extracted retrospectively from various sources. the study intends to describe the current situation of a cohort of approximately 1000 ccs in germany aged 24 to 49 years with respect to cardiovascular health. the role of risk factors (treatment related and classic cardiovascular risk factors), as well as related predisposing genetic factors is investigated. the results will contribute to recommendations to improve follow-up care.


Eligibility criteria:
inclusion criteria: 1. survivors of oncological disease according to iccc-3 aged \<15 years at diagnosis, diagnosed 1980-1990 while resident in germany 2. declaration of consent for storage of personal data at gccr exclusion criteria: 1. patient has refused contact with gccr 2. current address not available 3. second malignant neoplasm 4. diagnosis morbus hodgkin 5. diagnosis wilms tumor in 1990 6. former treating center recommends exclusion 7. insufficient knowledge of german language 8. inability to travel to the study center and participate in the examinations

Keywords: childhood cancer survivors cardiac vascular cardiovascular late-sequelae
exploring the feasibility of social skills training in people with psychosis

Conditions: Focus of Study

Summary: reduced social and community functioning is a predominant and enduring feature in people experiencing severe mental illness such as psychosis. the large majority of interventions (mostly pharmacological) target the so called positive symptoms (e.g. hallucinations and delusions) but poorly address functional and social consequences of the illness. this study attempts to fill this gap by assessing the feasibility and acceptability of a psychological intervention targeting social cognition deficit in people with psychosis. the intervention is a group psychological treatment facilitated by a clinical psychologist targeting competencies such as emotion recognition, social situation appraisal and guessing people's intentions and mental states. the group therapy takes advantage of audiovisual material to illustrate strategies and thinking styles that may help participants to overcome difficulties in social settings. a second objective of this study is to test a new method to measure social cognition. recent research showed that interview and performance based tests are poorly associated with every day activity of people with schizophrenia. this study is planning to evaluate the feasibility of new assessment methods for social cognition in everyday life using portable electronic devices (experience sampling method and an activity watch). these devices will be carried by participants in their everyday life and will ask about feelings and levels of social activities at random times and record basic physiological and activity levels.


Eligibility criteria:
inclusion criteria: diagnosis part of the psychosis spectrum (according to dsm-iv or dsm-v or icd-10); age 18-65 yrs; good command of the english language; social engagement problems as evidenced by care coordinator report and number of hours spent in social activities per week lower than 10. exclusion criteria: primary diagnosis of substance abuse disorder; change in antipsychotic medication in the last six weeks; significant learning difficulties (premorbid iq lower than 70).
a retrospective clinical study on the first-line maintenance treatment of ptcl with chidamide.

Conditions: PTCL

Summary: the efficacy and safety of chidamide in first-line maintenance therapy for ptcl will be assessed through a retrospective case analysis.

the study design belongs to a retrospective study, collecting information on patients with ptcl who were diagnosed and treated with chidamide as maintenance therapy at our center. the collected data includes age, gender, previous treatment regimens, results of auxiliary examinations (such as blood routine, biochemistry, bone marrow cytology, pathology, flow cytometry, ngs, etc.), as well as pet-ct images. the safety and efficacy of chidemide as first-line maintenance therapy in ptcl will be analyzed.

Eligibility criteria:
inclusion criteria: * (1) age: 18 years and older; (2) gender: male/female; (3) diagnosed with ptcl; (4) received chidamide as maintenance therapy after first-line treatment. exclusion criteria: * (1) patients with other types of lymphomas; (2) pregnant women.

Keywords: chidamide maintenance treatment
the impact of diaphragmatic breathing instructions and inspiratory pressures on diaphragm contraction in healthy adults

Conditions: Diaphragm

Summary: this is a cross-sectional obsessional study. this study aims (1) to investigate the relationship between sternocleidomastoid muscle recruitment and diaphragm thickness fraction during increasing inspiratory resistance in healthy adults; (2) to compare diaphragmatic and sternocleidomastoid muscle recruitment patterns with and without a standard diaphragmatic breathing instruction with increasing inspiratory resistance in healthy adults. participants will be asked to breathe through a pressure threshold inspiratory loading device under different inspiratory resistances with and without a standard diaphragmatic breathing instruction. sternocleidomastoid muscle activity will be measured with surface electromyography, and diaphragm thickness will be assessed with ultrasonography.

upon arrival at the laboratory, eligible participants will first perform a standard spirometry lung function test. the maximum inspiratory pressure (mip) will be determined with a pressure threshold inspiratory loading device (powerbreathe, k2). each participant will then be instructed to use the device to perform, in random order, 10 breaths at an inspiratory intensity of 30%, 40%, 50%, 60%, 70%, and 80% mip. a rest period of 15 minutes will be allowed between each inspiratory pressure set of 10 breaths. simultaneous surface electromyographic (semg) recording of the right sternocleidomastoid muscle and ultrasound of right diaphragmatic thickness will be conducted during each breath. the entire recording procedure will be repeated on a separate day. during the repeat measurements, participants will be provided with specific breathing instruction to focus on the use of the diaphragm and to inhale air to the lower part of the chest. practice trials will be conducted to ensure participant's understanding of diaphragmatic breathing.

Eligibility criteria:
inclusion criteria: * participants ≥18 years of age with normal health exclusion criteria: * pregnancy. * participants with known cardiovascular, pulmonary, musculoskeletal or psychiatric disorders. * participants with respiratory symptoms (from flu or other respiratory infection during the 2 weeks prior to measurements. * participants can not cooperate the maximal inspiratory pressure measurement.

Keywords: diaphragmatic thickening fraction sternocleidomastoid muscles inspiratory pressures
an observational study of neorecormon (epoetin beta) in cancer patients with anemia (fast)

Conditions: Anemia, Neoplasms

Summary: this observational study will evaluate the clinical benefit of neorecormon (epoetin beta) in daily routine practice in cancer patients with anemia. data will be collected from patients who are receiving chemotherapy for a solid tumor or hematological malignancy. patients will be followed for 28 weeks.


Eligibility criteria:
inclusion criteria: * adult patients, \>/=18 years of age * patients receiving myelosuppressive chemotherapy for a solid tumor, a hematological malignancy or an autograft for hematological malignancy * patients for whom treatment with epoetin beta is started at the inclusion visit * life expectancy \>/=6 months according to the physician * patients accepting and able to complete a french written questionnaire about his/her professional and social activities at each visit exclusion criteria: * patients who received erythropoiesis-stimulating agents treatment, or red blood cell transfusion within 4 weeks before enrollment * participation in a clinical trial in onco-hematology * patients with myelodysplasia * patients with more than one active malignancy at the time of enrollment